Title

Optimising basal-bolus therapy in type 2 diabetes: A randomised, controlled trial comparing bolus insulin delivery using an insulin patch vs an insulin pen

Document Type

Conference Proceeding

Publication Date

2018

Publication Title

Diabetologia

Abstract

Background and aims: This multicenter randomized, controlled trial compared efficacy, safety, and subject-reported outcomes for adults with type 2 diabetes on basal insulin (HbA1c 7.5-11% [58-97 mmol/mol]) initiating mealtime insulin (aspart) with a wearable bolus insulin delivery patch (Patch) vs an insulin pen (Pen). The Patch was applied at least every 3 days and delivered subcutaneous bolus insulin in 2-U increments per manual click. Materials and methods: Subjects (n = 278, mean age: 59 years, mean diabetes duration: 15 years) receiving 0.52 U/kg glargine on average, were randomized to Patch (n = 139) or Pen (n = 139). Baseline glargine dose was divided 1:1 into basal:bolus. Using a pattern-control logbook, subjects adjusted basal and bolus insulin weekly based on fasting and premeal glucose targets. Results: Change in HbA1c from baseline toWeek 24 (primary endpoint) for Patch was non-inferior (p < 0.0001) to Pen (least squares mean change ± SEM: Patch, -1.7 ± 0.1% [-19 ± 1.0 mmol/mol] vs Pen, -1.6 ± 0.1% [-17 ± 1.0 mmol/mol]); this reduction was significant (p < 0.0001) in both groups. HbA1c improvement was maintained at 44 weeks (Figure). At Week 24, 63% of Patch users and 56% of Pen users achieved HbA1c ≤7.0% (≤53 mmol/mol) (OR, 1.3; SEM, 0.25; 95% CI, 0.81, 2.14; p = 0.26). The proportions of Patch and Pen users who achieved HbA1c ≤7.0% (≤53 mmol/mol) at Week 44 rose to 65% and 63%, respectively (OR, 1.2; SEM, 0.28; 95% CI, 0.64, 1.93; p = 0.71). CVof 7-point selfmonitoring blood glucose decreased significantly more with Patch compared to Pen; change from baseline toWeek 44 was -1.2 ± 0.8% and 1.4 ± 0.8%, respectively (difference, -2.6 ± 1.1%; 95% CI, -4.8, -0.4; p = 0.022). Subjects in Patch and Pen arms, respectively, reported high adherence (mean ± SEM, %) to their insulin regimens atWeek 24 (79 ± 18% vs 78 ± 16%; p = 0.70) and Week 44 (81 ± 15% vs 81 ± 17%; p = 0.78). There were no significant differences in adverse events, including hypoglycemia (3 severe episodes/group). There were significantly greater improvements in subject-reported outcomes for Patch vs Pen. Conclusion: Bolus insulin with Patch or Pen and dosing algorithms improved HbA1c with better experience and preference for Patch. (Figure Presented)

Volume

61

First Page

S397

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